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FR901228 in Treating Patients With Recurrent Small Cell Lung Cancer
This study has been completed.
Study NCT00086827   Information provided by National Cancer Institute (NCI)
First Received: July 8, 2004   Last Updated: July 23, 2008   History of Changes

July 8, 2004
July 23, 2008
May 2004
Objective response rate [ Designated as safety issue: No ]
Objective response rate
Complete list of historical versions of study NCT00086827 on ClinicalTrials.gov Archive Site
 
 
 
FR901228 in Treating Patients With Recurrent Small Cell Lung Cancer
A Phase II Study Of Single Agent Depsipeptide (FK228)(NSC630176; 51,810) In Relapsed Small Cell Lung Cancer

RATIONALE: FR901228 may stop the growth of tumor cells by blocking the enzymes necessary for their growth.

PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with recurrent small cell lung cancer.

OBJECTIVES:

Primary

  • Determine the response rate in patients with recurrent small cell lung cancer treated with FR901228(depsipeptide).

Secondary

  • Determine the overall and failure-free survival of patients treated with this drug.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity. Patients who have continuing tumor response or stable disease after 6 courses receive 2 additional courses beyond best response.

Patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 15-36 patients will be accrued for this study within 4-18 months.

Phase II
Interventional
Treatment, Open Label
Lung Cancer
Drug: romidepsin
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
February 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed small cell lung cancer
  • Recurrent disease after 1, and only 1, prior platinum-based chemotherapy regimen (either cisplatin or carboplatin)

    • Completed therapy ≥ 90 days before documentation of relapse
  • Measurable disease

    • At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
    • The following are considered non-measurable lesions:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Abdominal masses that are not confirmed and followed by imaging techniques
      • Cystic lesions
      • Tumor lesions situated in previously irradiated area
  • Treated or controlled brain metastases allowed

    • No requirement for further radiotherapy or steroid therapy to control peri-tumoral edema

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Granulocyte count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • AST ≤ 2.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN

Renal

  • Creatinine ≤ 1.5 times ULN OR
  • Creatinine clearance 60-150 mL/min for males and 60-130 mL/min for females

Cardiovascular

  • LVEF > 40% by MUGA
  • QTc < 500 msec
  • No significant cardiac disease
  • No New York Heart Association class III or IV congestive heart failure
  • No myocardial infarction within the past year
  • No uncontrolled dysrhythmias
  • No poorly controlled angina
  • No left ventricular hypertrophy by echocardiograph or EKG
  • No prior serious ventricular arrhythmia (ventricular tachycardia or ventricular fibrillation ≥ 3 beats in a row)

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 6 weeks after study participation
  • No prior allergic reaction attributed to compounds of similar chemical or biological composition to FR901228

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

  • See Disease Characteristics
  • No prior FR901228 (depsipeptide)
  • No other concurrent chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • No concurrent hormones except for the following:

    • Steroids given for adrenal failure
    • Hormones administered for non-cancer-related conditions (e.g., insulin for diabetes)
    • Intermittent dexamethasone as an antiemetic

Radiotherapy

  • See Disease Characteristics
  • At least 4 weeks since prior radiotherapy
  • No concurrent palliative radiotherapy

Surgery

  • At least 2 weeks since prior major surgery and recovered

Other

  • No concurrent agent that causes QTc prolongation
  • No concurrent enzyme-inducing anticonvulsant drugs (e.g., phenytoin, phenobarbital, carbamazepine, felbamate, or primidone)
  • No concurrent combination antiretroviral therapy for HIV-positive patients
  • No concurrent potassium-wasting diuretics (e.g., hydrochlorothiazide)
  • No other concurrent histone deacetylase inhibitors (e.g., phenylbutyrate, valproic acid, or suberoylanilide hydroxamic acid)
  • No other concurrent investigational agent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00086827
 
CDR0000371616, CALGB-30304
Cancer and Leukemia Group B
National Cancer Institute (NCI)
Study Chair: Gregory A. Otterson, MD Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
National Cancer Institute (NCI)
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP